In drug development many applications are found for lipid-based nanoparticles (Lb-NPs) as successful transporters
for poorly water-soluble drugs and oligonucleotides in gene therapy.
Major advantages of lipids are their
high biocompatibility and biodegradability. In addition, advanced formulations using Lb-NP encapsulation of active ingredients can strongly contribute to targeted drug delivery in the body as well as stability and storage of the formulation.
The most important current medical applications include
cancer therapeutics and some of the current
COVID-19 vaccines.
Development and manufacturing of Lb-NP products often involves complex processes that need to be thoroughly understood and controlled to ensure optimum and constant quality of the medicine for patients. Therefore,
Bioprocess Optimization and Digital Bio-manufacturing Market 2021 Global Analysis, Opportunities And Forecast To 2026
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Process Analytical Technology (PAT) Market 2021 Global Industry Size, Share, Price, Trend and Forecast to 2026
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Introduction To ASTM E3263-20:
By Andrew Walsh, Ralph Basile, Ovais Mohammad, Stéphane Cousin, Mariann Neverovitch, and Osamu Shirokizawa
Part of the
series
Visual inspection has been widely used for many years by the pharmaceutical, biologics, and medical device industries after cleaning to release manufacturing equipment and devices. However, visual inspection has never been demonstrated to be an effective, reliable, or safe method to use for these inspections. Recently, the European Medicines Agency (EMA) issued a Q&A
1 to its guideline on determining health-based exposure limits (HBELs) that describes what criteria have to be met for visual inspection to be acceptable to the EMA for release of manufacturing equipment. Some form of guidance or a standard has been needed to guide these industries on how to meet these criteria and demonstrate that operators/QA inspectors are capable and qualified to accurately assess the absence or presence of residues on manufacturing equip
Providers of Groundbreaking PAT for Nanoparticle Characterization
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